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Generic Lipitor Recalled - Another Sign The FDA Needs Help?

WASHINGTON, DC - NOVEMBER 15: Commissioner of Food and Drug Administration Peggy Hamburg testifies during a hearing before the Senate Health, Education, Labor and Pensions Committee November 15, 2012 on Capitol Hill in Washington, DC. The hearing was focused on the meningitis outbreak originating at a Massachusetts pharmacy that has killed 32 people and sickened 461 more. (Image credit: Getty Images via @daylife)

Ingesting glass does not lower your cholesterol, but patients taking Ranbaxy’s generic version of Pfizer‘s blockbuster cholesterol-lowering drug Lipitor might be doing just that. Ranbaxy announced today that it was recalling a large number of batches of its generic Lipitor as they might include very small glass particles – something that could be dangerous if ingested.

Generics from other manufacturers have not been recalled. The recall is a small positive for Pfizer, which makes branded Lipitor. Pfizer has a generic drug division named Greenstone and some consumers might feel most comfortable asking for the Greenstone generic Lipitor.

The Ranbaxy recall comes after a host of problems with Ranbaxy in recent years – including recalls, admissions of false testing data presented to the FDA, and other manufacturing problems. The troubles at Ranbaxy also point to the challenge a foreign drug company has when buying another drug company. Almost immediately after Daiichi Sankyo acquired a majority stake in Ranbaxy, problems sprang up. With no expertise running an Indian generics drug company, let alone one that had been family controlled up to that point, DaiichiSankyo was blindsided by the troubles.

Ranbaxy shares dropped only 3% on this news today, but both Ranbaxy and Daiichi Sankyo shares have fallen since the two have paired up. Daiichi Sanko acquired a nearly 70% stake in Ranbaxy for approximately $4.8 billion according to Sankyo materials in 2008, with an initial price of approximately Rs 737 per share. Ranbaxy’s stock is now trading at Rs 496.

Daiichi Sankyo stock was approximately ¥3000 when the deal for Ranbaxy was announced, and now stands at ¥1267. While a market fall and global recession have happened in the intervening years, it is safe to say that Ranbaxy has not turned out nearly as well as Daiichi Sankyo had hoped.

Is The FDA Just “A Little Too Little, A Little Too Late”

This recall of the US’s most prescribed drug comes at a bad time for the FDA – now dealing with the fallout from the meningitis outbreak from a compound pharmacy and just a short time after the FDA recalled another high profile drug – the generic version of the blockbuster anti-depressant Wellbutrin XL after it was found not to work like the brand drug. Additionally, in recent years the FDA has been criticized for being too lenient with manufacturers, such as with the negotiated J&J phantom recall two years ago. While some might argue it is good that the FDA caught this problem and that is the sign things are working, others might criticize the FDA for approving Ranbaxy’s generic Lipitor while knowing how poor Ranbaxy’s history has been. Was the FDA being pressured by industry, payors and generic drug companies, to get an approval out given how large Lipitor was to public health spending? We don’t know. But what we do know is that each time the FDA has a high profile recall like generic Lipitor or Wellbutrin XL, scrutiny of future approvals increases. While the FDA’s catching a problem is good, more scrutiny is needed to determine why such problems occurred in the first place. Whether this recall will impact already-delayed timelines is another unknown, but it seems like that is a logical conclusion for a monitoring system that seems to be succeeding at catching problems, but not until the products are in consumer hands and bodies.

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Company has to have responsibility of the process rather FDA. FDA can only ensure that companies produce and sell only quality product. If the manufacturing practices are not producing quality product let us not penalize FDA but demand such manufacturing practices be stopped.

I am surprised that Ranbaxy has put forth $500 million dollars for Lipitor and other approvals but have not learnt from their mistakes.

Good Grief!! what the heck it’s always something! out there hurting people as if we don’t have enough stresses in life but to have to worry about swallowing glass now! while we are trying to stay alive for our Family’s Seems the FDA does need help and supervision The Government needs to get off there butts and Do something to help the United States of America! Seems to me the whole house needs cleaned out! and the way past due changes need made! Geeze

Lack of motivation to do a good job to protect people! To put the right people where there needed to make sure the products are doing what they should! It comes down to pure Laziness along with lack of intelligence!

Iuse to take the original LIPITOR untill my doctor took me off of it,and put me on ASTORVASTATIN WHICH IS GENERIC FOR LIPITOR AND IT IS Mfg.BY RANBAXY . BUT WHEN I ASKED MY DOCTOR WHY HE WAS CHANGING MY REGULAR LIPITOR TO atorvastatin and he did not give me a good answer .

I had no idea how bad BIG PHARMA and the FDA are until a friend was prescribed Nexium. Why has a drug with class action suits in at least one third of the USA states not been recalled? I ask this especially in light of the fact that Nexium is the over the counter version of Prilosec – exact compound, just stronger. This is a complete scam costing lives. Where is the FDA on this? “No problems”.